Singapore HSA registration DE0505364
OTU WiScope Digital Endoscope System
Singapore·CLASS B·OTU Medical Inc·Registered January 19, 2021Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0505364
- Registration Date
- January 19, 2021
- Retention Due Date
- January 18, 2026
Product description
WiScope® Digital Endoscope System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.
Product Owner
- Name
- OTU Medical Inc
- Short Name
- OTU Medical Inc
- Address
- 2231A Fortune Drive, San Jose, CA, 95131, UNITED STATES
Registrant
- Address
- 2 ANG MO KIO STREET 64, ECON INDUSTRIAL BUILDING, #05-02A, SINGAPORE 569084
Importer
- Address
- 40 JALAN PEMIMPIN, TAT ANN BUILDING, #03-01C, SINGAPORE 577185
Model information
- Model Name(s)
- WiScope®Single-Use Digital Flexible Ureteroscope, Reverse Deflection model WiScope®Single-Use Digital Flexible Ureteroscope, Reverse Deflection model WiScope®Single-Use Digital Flexible Ureteroscope, Standard Deflection model WiScope®Single-Use Digital Flexible Ureteroscope, Standard Deflection model WiScope�Image System
- Model Identifier(s)
- OTU-100RL OTU-100RR OTU-100SL OTU-100SR OTU-A
About this record
Access comprehensive regulatory information for OTU WiScope Digital Endoscope System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505364 and owned by OTU Medical Inc. The device was registered on January 19, 2021.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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